Surgical guiding tools and systems and methods of manufacturing surgical guiding tools

ABSTRACT

The present application relates to surgical guiding tools that may be used for guiding a surgical instrument during bone surgery. A surgical guiding tool may include a body including one or more clamps configured to attach the surgical guiding tool to one or more portions of the bone, wherein a first clamp of the one or more clamps includes a snap-fit portion including a flexible structure for increasing a clamping force of the first clamp and allowing ease of removal of the surgical guiding tool from the bone. The surgical guiding tool may further include at least one aperture for guiding a surgical instrument. The present application further provides methods for manufacturing surgical guiding tools and uses of the tools for placement onto a bone.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional PatentApplication No. 61/693,525, filed on Aug. 27, 2012, the entiredisclosure of which is hereby incorporated by reference.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present application relates to surgical guiding tools for use inguiding a surgical instrument during orthopedic surgery. Thisapplication also relates to methods for manufacturing surgical guidingtools and methods for using the surgical guiding tools in bone surgery.

2. Description of the Related Technology

Surgical guiding tools assist surgeons and have wide applications inorthopedic surgery. Surgical guiding tools may allow a surgeon toaccurately transfer a preoperative surgical plan into the operatingroom. Further, surgical guiding tools may help guide a surgicalinstrument, such as a cutting or drilling instrument, along apre-defined cutting or drilling path.

Problems may arise when adjustable surgical guiding tools, which mayinclude components that can be positioned to attach to or around a partof the bone, are unstable or provide inaccurate surgical instrumentguiding positions. For example, a surgical guiding tool may not fit wellon a patient's bone and may be unstable as a result. Furthermore, theguiding position for a surgical instrument may be imprecise because ofthe amount of distance between the supporting anatomy and the plannedpoint of entry of the surgical instrument. Still further, surgicalguiding tools may be large or bulky, and may require the availability ofa large surgical window.

In light of these and other deficiencies recognized by the inventors,there is a need for surgical guiding tools that provide secure andstable attachment to a patient's bone and that provide the ability toaccurately and efficiently guide a surgical instrument into or onto thepatient's bone.

SUMMARY

Various implementations of systems, methods and devices within the scopeof the appended claims each have several aspects, no single one of whichis solely responsible for the desirable attributes described herein.Without limiting the scope of the appended claims, some prominentfeatures are described herein.

The present application relates generally to surgical guiding tools thatmay be patient-specific. Details of one or more implementations of thesubject matter described in this specification are set forth in theaccompanying drawings and the description below. Other features,aspects, and advantages will become apparent from the description, thedrawings, and the claims.

One aspect of the subject matter described in the disclosure provides asurgical guiding tool for a bone. The surgical guiding tool includes abody including one or more clamps configured to attach the surgicalguiding tool to one or more portions of the bone, wherein a first clampof the one or more clamps includes a snap-fit portion including aflexible structure for increasing a clamping force of the first clampand allowing ease of removal of the surgical guiding tool from the bone.The body further includes at least one aperture for guiding a surgicalinstrument.

Another aspect of the subject matter described in the disclosureprovides a method of manufacturing a surgical guiding tool. The methodincludes designing the surgical guiding tool to create a surgicalguiding tool design, wherein the surgical tool design includes a bodyincluding one or more clamps configured to attach the surgical guidingtool to one or more portions of a bone, wherein a first clamp of the oneor more clamps includes a snap-fit portion including a flexiblestructure for increasing a clamping force of the first clamp andallowing ease of removal of the surgical guiding tool from the bone. Thebody further includes at least one aperture for guiding a surgicalinstrument. Furthermore, the method includes manufacturing the surgicalguiding tool based on the surgical guiding tool design.

Yet another aspect of the subject matter described in the disclosureprovides a femoral surgical guiding tool for a distal end of a femur.The femoral surgical guiding tool includes a body including an anteriorportion configured to attach the surgical guiding tool to one or moreosteophytes on an anterior region of the femur. The body furtherincludes one or more clamps configured to attach the surgical guidingtool to one or more condyles of the femur and at least one aperture forguiding a surgical instrument.

BRIEF DESCRIPTION OF THE DRAWINGS

The following description of the figures is merely exemplary in natureand is not intended to limit the present teachings, their application oruses. Throughout the drawings, corresponding reference numerals indicatelike or corresponding parts and features. Note that the relativedimensions of the following figures may not be drawn to scale.

FIG. 1 a illustrates an example of an anterior view of a femur.

FIG. 1 b illustrates examples of alternative views of a femur.

FIGS. 2 a and 2 b illustrate an example of a surgical guiding toolconfigured to attach to a bone.

FIG. 3 illustrates another example of a surgical guiding tool configuredto attach to a bone and including a flexible structure.

FIG. 4 illustrates yet another example of a surgical guiding toolconfigured to attach to a bone and including a flexible structure.

FIG. 5 illustrates an example of a flexible structure for use with asurgical guiding tool.

FIG. 6 illustrates another example of a flexible structure for use witha surgical guiding tool.

FIGS. 7 a and 7 b illustrates an example of a clamping structure thatmay act as a retractor.

FIGS. 8 a and 8 b illustrates an example of a surgical guiding toolconfigured to attach to a spine.

FIG. 9 illustrates an aspect of a method of manufacturing a surgicalguiding tool.

DETAILED DESCRIPTION OF CERTAIN INVENTIVE EMBODIMENTS

The following detailed description is directed to certain specificembodiments. However, the teachings herein can be applied in a multitudeof different ways. In this description, reference is made to thedrawings wherein like parts are designated with like numeralsthroughout.

The present application will be described with respect to particularembodiments but the invention is not limited thereto but only by theclaims.

As used herein, the singular forms “a”, “an”, and “the” include bothsingular and plural referents unless the context clearly dictatesotherwise.

The terms “comprising”, “comprises” and “comprised of” as used hereinare synonymous with “including”, “includes” or “containing”, “contains”,and are inclusive or open-ended and do not exclude additional,non-recited members, elements or method steps. The terms “comprising”,“comprises” and “comprised of” when referring to recited components,elements or method steps also include embodiments which “consist of”said recited components, elements or method steps.

Furthermore, the terms first, second, third and the like in thedescription and in the claims, are used for distinguishing betweensimilar elements and not necessarily for describing a sequential orchronological order, unless specified. It is to be understood that theterms so used are interchangeable under appropriate circumstances andthat the embodiments of the invention described herein are capable ofoperation in other sequences than described or illustrated herein.

Reference throughout this specification to “one embodiment” or “anembodiment” means that a particular feature, structure or characteristicdescribed in connection with the embodiment is included in at least oneembodiment of the present application. Thus, appearances of the phrases“in one embodiment” or “in an embodiment” in various places throughoutthis specification are not necessarily all referring to the sameembodiment, but may. Furthermore, the particular features, structures orcharacteristics may be combined in any suitable manner, as would beapparent to a person skilled in the art from this disclosure, in one ormore embodiments. Furthermore, while some embodiments described hereininclude some but not other features included in other embodiments,combinations of features of different embodiments are meant to be withinthe scope of the application, and form different embodiments, as wouldbe understood by those in the art. For example, in the appended claims,any of the features of the claimed embodiments can be used in anycombination.

The term “about” as used herein when referring to a measurable valuesuch as a parameter, an amount, a temporal duration, and the like, ismeant to encompass variations of +/−10% or less, preferably +/−5% orless, more preferably +1/−1% or less, and still more preferably +1/−0.1%or less of and from the specified value, insofar as such variations areappropriate to perform in the disclosed invention. It is to beunderstood that the value to which the modifier “about” refers is itselfalso specifically, and preferably, disclosed.

The recitation of numerical ranges by endpoints includes all numbers andfractions subsumed within the respective ranges, as well as the recitedendpoints.

The present application discloses surgical guiding tools that may bepatient-specific. The surgical guiding tools provide accurate and stableattachment to a bone, which allows stable and accurate introduction of asurgical instrument into the bone. This application further describesmedical-image-based surgical guiding tools that may be patient specific.These patient-specific tools may provide the ability to accuratelyinsert a surgical instrument into the patient's bone according to apredefined planning.

The term “patient-specific” as used herein refers to the surgicaldevices, tools, and/or guides as described herein, which are designedstarting from an individual patient's anatomy to providepatient-specific devices, tools, or guides having a custom fit orfunctioning in a unique, customized manner for a particular individualpatient. The use of patient-specific devices, tools, or guides allowsfor improved or optimized surgical interventions, orthopedic structures,and/or kinematics for the patient. Similar benefits are obtained whensuch patient-specific devices are used in combination with standardimplants, tools, devices, surgical procedures, and/or other methods.

In some embodiments, a surgeon or physician during pre-operativeprocedures may identify various regions of a bone of a specific patient,such as those described below with respect to the femur 100, and maydetermine, based on the identified regions of the bone, an optimaldesign for various surgical guiding tool components (e.g., a clamp,body, aperture, etc. of a surgical guiding tool). A surgeon or physicianmay further determine optimal locations for attaching a surgical guidingtool based on the identified regions of the bone. Pre-operativeprocedures often involve obtaining an image of a patient's bone prior toperforming surgery. Digital patient-specific image information may beprovided by any suitable means known in the art, such as, for example, acomputer tomography (CT) scanner, a magnetic resonance imaging (MRI)scanner, an x-ray, or an ultrasound scanner.

An advantage of the surgical guiding tools described in the presentapplication provides that sufficient information may be obtained fordesigning a guiding tool for secure and stable placement onto apatient's bone based on either CT or MRI images. Cartilage regions ofbones may not be visible on the images of CT scans, and, as a result,these cartilage regions may not be used to fit a surgical guiding toolon the patient. A physician may be unable to locate an optimal positionor region on the bone for attachment of the surgical guiding tool due tothe limited regions of the bone that are visible to the physician. Thus,available attachment regions on the bones for guiding tools may belimited. Accordingly, surgical guiding tools that are able to provide asecure and stable attachment to the bone, along with methods foridentifying optimal locations on the bone, even with limited attachmentregions are desirable.

Pre-operative planning may include the construction of a threedimensional (3D) virtual model of a bone, or part thereof. In someembodiments, construction of the 3D virtual model may begin withscanning of a patient. For example, the scanning may include using ascanning technique that generates medical volumetric data, such as a CTscan, a MRI scan, or the like. In some embodiments, the output of thescan may include a stack of two-dimensional (2D) slices forming a 3Ddata set. The output of the scan may be digitally imported into acomputer program and may be converted using algorithms known in thefield of image processing technology to produce a 3D computer model ofthe bone. For example, the virtual 3D model may be constructed from thedata set using a computer program such as Mimics™ as supplied byMaterialise N.V., Leuven, Belgium. Once the 3D volume of the bone, or apart thereof, is reconstructed, the surgeon may define the preferredposition, orientation, depth and diameter of the bores and drill pathsthat are needed for the surgery. Based on the determined surgical needs,the surgeon or a physician may design, manufacture, and/or manipulate asurgical guiding tool to meet the needs of the specific patient.

FIG. 1 a illustrates one example of an anterior view of a femur 100.While the description herein describes a femur, one of skill in the artwill understand that the content of the present application appliesequally to other bones, such as the humerus, scapula, tibia, fibula,talus, and other shoulder, hip, ankle, and/or finger bones. The anteriorregion depicted in FIG. 1 a is located at the distal end of the femur100. This anterior region of the femur 100 may provide a portion 102that may be used to attach and secure a surgical guiding tool thereto.For example, osteophytes may be located on the anterior region of thefemur 100, and may be used to attach a surgical guiding tool to thefemur 100. An osteophyte is a bony projection that forms along bones,such as at a joint, and may occur in patients with arthritis. One ormore osteophytes projecting from the surface of a femur, for example,may provide a surface from which a surgical guiding tool may be attached(e.g., in whole or in part). A medial condyle 108 and a lateral condyle110 are also located at the distal end of the femur 100. Holes 104 and106 may be aligned with one or more apertures of a surgical guiding tooland may be created using a surgical tool device (e.g., a surgical drill)inserted into the one or more apertures. Details regarding variousembodiments of surgical guiding tools will be discussed below.

FIG. 1 b illustrates examples of alternative views of the femur 100illustrated in FIG. 1 a. In particular, FIG. 1 b illustrates the medialcondyle 108 and the lateral condyle 110 located at the distal end of thefemur 100. The medial 108 and lateral 110 condyles may also provide oneor more portions that may be used to attach and secure a surgicalguiding tool thereto. For example, a lateral region 112 and a medialregion 114 of the medial condyle 108 may be used to attach and secure asurgical guiding tool. In some embodiments, lateral and medial regionsof the lateral condyle 110 may be used to attach and secure a surgicalguiding tool. For example, lateral and medial regions of the lateralcondyle 110 may be used in addition to the lateral region 112 and medialregion 114 of the medial condyle 108 to attach a surgical guiding toolto the femur 100. As another example, only the lateral and medialregions of the lateral condyle 110 may be used as an alternative to thelateral region 112 and medial region 114 of the medial condyle 108. Insome embodiments, osteophytes located on the medial condyle 108 and/orthe lateral condyle 110 may be used to attach and secure a surgicalguiding tool.

In some embodiments, as indicated above, the patient-specific regions ofa bone may comprise specific anatomical features that may be used toattach a surgical guiding tool. Detailed geometrical, patient-specificinformation is used in the design and manufacture of a surgical guidingtool in order to determine those surfaces of the bone that are suitablefor this purpose. For example, as described above, one or moreosteophytes projecting from the surface of a bone, such as a femur, mayprovide a surface from which a surgical guiding tool may be attached. Inaddition to the osteophytes, a medial condyle 108 and/or a lateralcondyle 110 may provide one or more portions that may be used to attachand secure a surgical guiding tool thereto. In some embodiments, themedial condyle 108 and/or the lateral condyle 110 may be used to attacha surgical guiding tool to the bone independently of the one or moreosteophytes.

A method of manufacturing a surgical guiding tool may include designingthe surgical guiding tool to create a surgical tool design, which mayinclude identifying and selecting at least one part of a bone thatcontains specific features that may allow attachment of the surgicalguiding tool. For example, a surgical guiding tool for a bone may bedesigned and manufactured, and may comprise a body including one or moreclamps. The clamps may take various forms and perform various functionsincluding, but not limited to, attaching and/or securing the guidingtool to a bone. In some embodiments, the clamps are configured to attachthe surgical guiding tool to one or more portions of the bone, wherein afirst clamp of the one or more clamps includes a snap-fit portionincluding a flexible structure for increasing a clamping force of thefirst clamp and allowing ease of removal of the surgical guiding toolfrom the bone. The flexible structure may include any structure that canbe used to increase the clamping force of the first clamp and to easeremoval of the surgical guiding tool from the bone. For example, asdiscussed further below, the flexible structure may include a snap-fitportion with a material having a thickness that is less than the averagethickness of the remainder of the body. As another example, the flexiblestructure may include one or more attachment mechanisms, such as a groupof bands or chains or a honeycomb structure, that interconnect a firstportion (e.g., a medial portion) of the first clamp to a second portion(e.g., lateral) of the first clamp. Further examples of a flexiblestructure may include attachment mechanisms using one or more screws tolock an undercut portion in place, using a retractor, using a springloaded lock, using a spring combined with a hinge, using a push buttonlocking mechanism, etc. The flexible structure may further include areference mechanism that can be used to confirm that the surgicalguiding tool is properly attached to the bone. The surgical guiding tool(e.g., the body) may further comprise at least one aperture for guidinga surgical instrument. In another example, a femoral surgical guidingtool for a distal end of a femur may be designed and manufactured, andmay comprise a body including an anterior portion configured to attachthe surgical guiding tool to one or more osteophytes on an anteriorregion of the femur, and one or more clamps configured to attach thesurgical guiding tool to one or more condyles of the femur. In thisexample, the femoral surgical guiding tool (e.g., the body) may furthercomprise at least one aperture for guiding a surgical instrument.

Manufacturing and/or designing of a surgical guiding tool may furtherinclude determining the appropriate position of a guiding component ofthe surgical guiding tool (e.g., an aperture) with regard to the bone.In particular embodiments, this may be done based on the pre-operativeplanning of the desired path of the surgical tool in the bone. Theorientation of the guiding component may be such that the surgicalinstrument is guided in the predetermined direction. Pre-operativeplanning by a physician makes it possible to determine the required pathof the surgical instrument, and accordingly, the required orientation ofthe guiding component. The pre-operative planning may be done usingsuitable dedicated software, based on suitable medical images (of whichCT, MRI, are examples), taking into account factors like bone qualityand proximity to nerve bundles/blood vessels, or other anatomicallysensitive objects. In some embodiments, preoperative images are importedinto a computer workstation running 3D software in order to plan andsimulate the surgery. The imported images may be manipulated as 3Dvolumes, and a computer simulation may be created, which outputs aplanning containing the information necessary for adapting theorientation of the guiding component.

Manufacturing of a surgical guiding tool may further comprisemanufacturing the surgical guiding tool based on the design. FIG. 7provides an example of a method of manufacturing a surgical guidingtool, and is described in further detail below.

FIGS. 2 a and 2 b illustrate an example of a surgical guiding tool 200configured to attach to a bone. In some embodiments, the surgicalguiding tool 200 may be a femoral surgical guiding tool for a distal endof a femur 212. While the description herein may describe a femur 212 asan example of the bone, one of skill in the art will understand that thecontent of the present application applies equally to other bones, suchas the humerus, scapula, tibia, fibula, talus, spine, and othershoulder, hip, ankle, and/or finger bones. The surgical guiding tool 200includes a body 202 that is configured to attach to at least one regionor portion of the femur 212. The body 202 includes a first portion 214,such as an anterior portion, that is configured to attach the surgicalguiding tool to an anterior region of the femur 212. For example, thefirst portion 214 may be configured to attach the surgical guiding tool200 to one or more osteophytes on the anterior region of a femur 212. Insome embodiments, the first portion 214 may be configured to attach thesurgical guiding tool to one or more osteophytes anywhere along a bone,such as one or more osteophytes on the distal end of a humerus. Thefirst portion 214 attaches and secures the surgical guiding tool 200 tothe femur 212. For example, the first portion 214 may be configured torest on one or more osteophytes and thus restrict undesired movement ofthe surgical guiding tool 200. In this example, as further describedbelow, a clamp 204 may be used to secure the surgical guiding tool 200to the femur 212. In some embodiments, the first portion 214 may includea flexible snap-fit portion for increasing a clamping force of the firstportion 214 to the femur 212 and allowing ease of removal of thesurgical guiding tool 200 from the femur 212. For example, the firstportion 214 may be manufactured from a flexible material that creates aclamping force for squeezing a portion of a femur 212 (e.g., anosteophyte), and at the same time allows a physician to easily removethe surgical guiding tool 200 from the femur 212.

The body 202 of the surgical guiding tool 200 further includes a clamp204 configured to attach the surgical guiding tool 200 to one or moreportions of the femur 212. For example, the clamp 204 may be configuredto attach the surgical guiding tool 200 to a condyle of the femur 212,such as the medial condyle as illustrated in FIGS. 2 a and 2 b. Thesecure attachment of the clamp 204 to a condyle ensures that thesurgical guiding tool 200 remains in a stable and secure position duringsurgery. The extent of displacement of the clamp 204 that is needed toplace the surgical guiding tool 200 onto the femur 212 depends on thethickness of the portion of the femur 212 (e.g., a condyle) that theclamp is to be attached and the extent to or the angle by which theclamp 204 spans the contour of the portion of the femur 212 uponplacement of the surgical guiding tool thereon. In some embodiments, anoverhang of the ends (referred to as an “undercut” portion) of the clamp204 is created when the surgical guiding tool 200 is placed on the femur212. For example, the undercut portion of the clamp 204 may form aclamping or snapping mechanism that encloses the condyle and creates astable and secure attachment of the surgical guiding tool 200 to thefemur 212. In some embodiments, the clamp 204 may include a snap-fitportion including a flexible structure for increasing a clamping forceof the clamp 204 and allowing ease of removal of the surgical guidingtool 200 from the femur 212. For example, a snap-fit portion of theclamp 204 including the flexible structure may be configured to allow astable and secure attachment of the surgical guiding tool 200 to acondyle of the femur 212 by increasing the clamping force of the clamp204, while allowing a physician to remove the surgical guiding tool 200from the femur 212 with ease. Details regarding different embodiments ofa snap-it portion of a clamp are described below. In some embodiments,the body 202 of the surgical guiding tool 200 may include more than oneclamp that is similar to clamp 204. For example, body 202 may include asecond clamp that may be configured to attach to the lateral condyle ofthe femur 212 in addition to the clamp 204. The use of a second clampmay add further stability of the surgical guiding tool 200 to the femur212.

The use of the first portion 214 along with one or more clamps, such asclamp 204, ensures that the surgical guiding tool remains secured to thefemur 212, or other bone, even with limited attachment regions on thebones for attaching the guiding tool (e.g., due to cartilage regions notbeing visible on the images of CT scans, as described above). Bysecuring the surgical guiding tool 200 in a stable manner using thefirst portion 214 and the one or more clamps, the surgical guiding toolmay be securely and accurately placed on the bone so that surgery may beperformed more accurately and safely due to little or no movement of theguide. For example, by attaching the first portion 214 to the anteriorregion of the femur 212 (e.g., to an osteophyte), and further attachingone or more clamps, such as clamp 204, to one or more condyles, thesurgical guiding tool 200 will be restricted from various translationaland rotational movements (e.g., posterior and anterior sliding, distaland proximal sliding, mediolateral sliding, internal-external rotation,varus-valgus movements, and/or flexion-extension).

The surgical guiding tool 200 further includes apertures 206, 208, and210, which may aligned with areas of the femur 212 corresponding tolocations that need to be accessed for surgery, such as locations whereholes are to be drilled. For example, holes 104 and 106 illustrated inFIG. 1 may be aligned with the apertures 206 and may be created using asurgical tool device inserted into the apertures 206, such as a drill,bur, saw, jig saw, lateral drill or any other cutting, milling ordrilling instrument. The apertures 206, 208, and 210 are positioned sothat a surgical tool device that is passed through one or more of theapertures 206, 208, and 210 can reach the bone at the desired location.The apertures 206, 208, and 210 may be positioned in any directionrelative to the bone as long as it provides access for a surgical tooldevice to reach the bone at the desired location. In some embodiments,the apertures 206, 208, and 210 may protrude from the surface of thebody 214, as illustrated in FIGS. 2 a and 2 b. In some embodiments, theapertures may include safety stops to prevent a surgical tool devicefrom advancing beyond a planned or determined depth into the bone. Whilethe description herein may describe apertures 206, 208, and 210 locatedat specific locations, one of skill in the art will understand that thecontent of the present application applies equally to aperture locationsrelating to patient-specific locations on different type of bones, andmay be determined using pre-operative procedures described above.Further, the orientation and position of the apertures may correspond topre-operative planning and procedures.

In some embodiments, the surgical guiding tool 200 may be a single,continuous structure (e.g., a single mold) that includes all of theguiding tool components, including the body 214, the apertures 206, 208,and 210, and the clamp 204. In some embodiments, the each component ofthe surgical guiding tool 200 may be a separate structure that isintegrated with the other components to create the surgical guiding tool200.

FIG. 3 illustrates another example of a surgical guiding tool 300configured to attach to a bone and including a flexible structure 316.In some embodiments, the surgical guiding tool 300 may be a femoralsurgical guiding tool for a distal end of a femur 312. While thedescription herein may describe a femur 312 as an example of the bone,one of skill in the art will understand that the content of the presentapplication applies equally to other bones, such as the humerus,scapula, tibia, fibula, talus, and other shoulder, hip, ankle, and/orfinger bones. Similar to the surgical guiding tool 200 illustrated inFIG. 2, surgical guiding tool 300 includes a body 302, a clamp 304,apertures 306, 308, and 310, and a first portion 314 (e.g., an anteriorportion). The body 302 is configured to attach to at least one region orportion of the femur 312 and includes a first portion 314, such as ananterior portion, that is configured to attach the surgical guiding toolto an anterior region of the femur 312. For example, the first portion314 may be configured to attach the surgical guiding tool 300 to one ormore osteophytes on the anterior region of a femur 312. In someembodiments, the first portion 314 may be configured to attach thesurgical guiding tool to one or more osteophytes anywhere along a bone,such as one or more osteophytes on the distal end of a humerus. In someembodiments, the first portion 314 may be configured to rest on one ormore portions of the femur 312 (e.g., one or more osteophytes) and thusrestrict undesired movement of the surgical guiding tool 300. In theseembodiments, the clamp 304 may be used to secure the surgical guidingtool 300 to the femur 312. In some embodiments, the first portion 314may include a flexible snap-fit portion for increasing a clamping forceof the first portion 314 to the femur 312 and allowing ease of removalof the surgical guiding tool 300 from the femur 312. For example, thefirst portion 314 may be manufactured from a flexible material thatcreates a clamping force for squeezing a portion of a femur 312 (e.g.,an osteophyte), and at the same time allows a physician to easily removethe surgical guiding tool 300 from the femur 312.

The clamp 304 is configured to attach the surgical guiding tool 300 toone or more portions of the femur 312, such as a medial condyle asillustrated in FIG. 3. The clamp 304 may include a snap-fit portionincluding flexible structure 316 for increasing a clamping force of theclamp 304 and allowing ease of removal of the surgical guiding tool 300from the femur 313. The snap-fit portion may be configured to allow astable and secure attachment of the surgical guiding tool 300 to acondyle of the femur 312 by increasing the clamping force of the clamp304, while allowing a physician to remove the surgical guiding tool 300from the femur 312 with ease. The flexible structure 316 of the snap-fitportion may include material having a thickness that is less than theaverage thickness of the remainder of the body 302. By manufacturing theflexible structure 316 of the snap-fit portion to be thinner than theremainder of the body, the desired flexibility of the clamp 304 of theguiding tool 300 may be obtained because the thinner portion introducesa weakened area in the clamp 304, which allows bending of the snap-fitportion of the clamp 304. For example, the flexible structure 406provides flexibility so that a physician is able to easily manipulatethe clamp 304 to fit around a condyle of the femur 312, and at the sametime provides a clamping force sufficient to securely attach thesurgical guiding tool 300 to the femur 312 in a stable and securemanner. In some embodiments, the flexible structure 316 may have athickness that is between ½ and ⅕ of the average thickness of theremainder of the body 302. In some embodiments, the minimum thickness ofthe flexible structure is about 2 mm, to maintain stability of thestructure. In some embodiments, the body 302 of the surgical guidingtool 300 may include more than one clamp that is similar to clamp 304.For example, body 302 may include a second clamp that may be configuredto attach to the lateral condyle of the femur 312 in addition to theclamp 304. The use of a second clamp may add further stability of thesurgical guiding tool 300 to the femur 212. In some embodiments, thebody 302 may include a first clamp, such as clamp 304, that includes asnap-fit portion including a flexible structure, such as flexiblestructure 316, and a second, non-flexible clamp (e.g., with an undercutportion). In some embodiments, the body 302 may include two or moreclamps that include a snap-fit portion including a flexible structure.

Apertures 306, 308, and 310 are similar to the apertures illustrated inFIG. 2, and may aligned with areas of the femur 312 that correspond tolocations that need to be accessed for surgery, such as locations whereholes are to be drilled. For example, drill holes 104 and 106illustrated in FIG. 1 may be aligned with the apertures 306 and may becreated using a surgical tool device inserted into the apertures 206,such as a drill, bur, saw, jig saw, lateral drill or any other cutting,milling or drilling instrument. In some embodiments, the apertures 306,308, and 310 may protrude from the surface of the body 314, asillustrated in FIG. 3. While the description herein may describeapertures 306, 308, and 310 located at specific locations, one of skillin the art will understand that the content of the present applicationapplies equally to aperture locations relating to patient-specificlocations on different type of bones, and may be determined usingpre-operative procedures described above.

FIG. 4 illustrates yet another example of a surgical guiding tool 400configured to attach to a bone, such as the femur 412, and including aflexible structure 406. The surgical guiding tool 400 includes a firstclamp 402 and a second clamp 410. The first clamp 402 may include asnap-fit portion including flexible structure 406 for increasing aclamping force of the first clamp 402 and allowing ease of removal ofthe surgical guiding tool 400 from the femur 412. The snap-fit portionmay be configured to allow a stable and secure attachment of thesurgical guiding tool 400 to a condyle of the femur 412 by increasingthe clamping force of the first clamp 402, while allowing a physician toremove the surgical guiding tool 400 from the femur 412 with ease. Theflexible structure 406 includes one or more attachment mechanisms, suchas a group of bands or chains, that interconnect a medial portion of thefirst clamp 402 to a lateral portion 404 of the first clamp 402. FIG. 5illustrates an example of the flexible structure 406. The one or moreattachment mechanisms of the flexible structure 406 provide the desiredflexibility of the first clamp 402 of the surgical guiding tool 400 andallow bending of the snap-fit portion of the clamp 402. The one or moreattachment mechanisms may include a group of bands or chains that aremade from a flexible material (e.g., silicone, rubber, etc.) thatprovides a flexible attachment of the clamp 402 to the femur 412. Forexample, the one or more attachment mechanisms of the flexible structure406 provides flexibility so that a physician can easily manipulate theclamp 402 to fit around the condyle of the femur 412, and at the sametime provides a clamping force sufficient to securely attach thesurgical guiding tool 400 to the femur 412 in a stable and securemanner. Each attachment mechanism of the flexible structure 406 mayfurther include one or more cylinders 408 (e.g., one cylinder for eachattachment mechanism) that add rigidity and stability to the flexiblestructure so that the clamp fits securely to the bone. Further, the oneor more cylinders 408 may increase the clamping force for securelyattaching the surgical guiding tool 400 to the femur 412.

FIG. 6 illustrates another example of a flexible structure 600 for usewith a surgical guiding tool, such as the surgical guiding toolsdescribed above. The flexible structure 600 includes a plurality ofholes, and may be shaped like a honeycomb structure. The flexiblestructure 600 may be used in place of the one or more attachmentmechanisms described above with respect to FIG. 5. For example, theflexible structure 600 may interconnect a medial portion of the firstclamp 402 to a lateral portion 404 of the first clamp 402. The pluralityof holes add flexibility so that a physician can easily manipulate aclamp using the flexible structure 600 to attach to a portion of a bone(e.g., a condyle of a femur). The plurality of holes further addrigidity for providing a clamping force sufficient to securely attachthe surgical guiding tool 600 to the bone in a stable manner. Theflexible structure 600 may be used to fit a clamp of a surgical guidingtool snugly around the condyle of a femur in order to provide a stableand secure fit of the surgical guiding tool to the femur.

One of skill in the art will understand that any flexible material maybe used as the material for the attachment mechanism. In someembodiments, only materials that are biocompatible (e.g., USP class VIcompatible) may be used as the attachment mechanism of the flexiblestructure 406.

In some embodiments, the second clamp 410 of the surgical guiding tool400 may include an undercut portion when the surgical guiding tool 400is placed on the femur 412. For example, an undercut portion of thesecond clamp 410 may form a clamping or snapping mechanism that enclosesa condyle, such as the lateral condyle illustrated in FIG. 4, andcreates a stable and secure attachment of the surgical guiding tool 400to the femur 412.

In some embodiments, the second clamp 410 may include a snap-fit portionincluding flexible structure for increasing a clamping force of theclamp 410 and allowing ease of removal of the surgical guiding tool 400from the femur 412. The flexible structure of the snap-fit portion mayinclude material having a thickness that is less than the averagethickness of the remainder of the body of the surgical guiding tool 400,or may include one or more attachment mechanisms similar to the flexiblestructure 406 of the first clamp 402.

In some embodiments, the surgical guiding tools 200, 300, and/or 400 maybe a single, continuous structure (e.g., a single mold) that includesall of the guiding tool components, including the body, the apertures,and the one or more clamps. In some embodiments, the each component ofthe surgical guiding tools 200, 300, and/or 400 may be a separatestructure that is integrated with the other components to create thesurgical guiding tools.

FIG. 7 a illustrates a clamping structure 700 that may act as aretractor. The clamping structure 700 includes a body 702 and a clamp704. The clamp 704 includes an engagement surface 706 that mayanatomically match part of a bone of a patient, such as a knee,shoulder, ankle, etc. In some embodiments, the clamping structure 700includes a coupling feature 708 that allows a removable coupling of thebody 702 and the clamp 704 to one another. For example, the couplingfeature 708 may form a dovetail coupling. The body 702 further includesa clipping portion 710 (e.g., a rotation clip).

FIG. 7 b illustrates an embodiment including the clamping structure 700used with a surgical guiding tool 712 (e.g., a patient specific surgicalguiding tool). For example, the surgical guiding tool 712 may be usedfor positioning on a shoulder bone 714. While the description herein maydescribe a shoulder bone 714 as an example of the bone, one of skill inthe art will understand that the content of the present applicationapplies equally to other bones, such as the femur, humerus, scapula,tibia, fibula, talus, and other shoulder, hip, ankle, and/or fingerbones. The surgical guiding tool may be used to guide the drilling of ahole in the bone 714 via a drill guide 716. The clamping structure 700may begin in a position suitable for insertion or removal of theclamping structure into the patient. The clipping portion 710 fits ontoa corresponding portion of the surgical guiding tool 712. The clamp 704of the clamping structure 700 comprises a retractor surface that matchesthe anatomy of the shoulder bone over which it will be applying forcewhen the retractor surface of the clamping structure is in its engagedposition. In FIG. 7 b, the clamping structure 700 is illustrated in anengaged position. In this position, the retractor surface of theclamping structure is engaged to the surgical guiding tool 712 and pullsthe guide towards the bone surface, thereby creating a clamp and thusproducing a secure and stable locking fit. The clamping structure 700further operates to pull back the skin of the patient while providingthe clamping force to the bone.

In some embodiments, the clamping structure 700 may be integrated with asurgical guiding tool, such as guiding tools 200, 300, 400, and/or 716,so that the surgical guiding tool includes a single structure includingthe clamping structure 700. Integration of the clamping structure 700with the surgical guiding tool allows a ratcheting clamping structurefor providing a secure and stable placement of the surgical guiding toolto a bone. In some embodiments, a surgical guiding tool may include twoclamping structures 700 on two opposite sides of the surgical guidingtool. Providing two clamping structures 700 allows a ratcheting force ontwo sides of the surgical guiding too, providing an even more stable andsecure clamping force.

In some embodiments, the clamping structure 700 used as a retractor mayinclude any structure for locking clamping structure 700 into place sothat a physician may operate without holding the retractor in place. Forexample, the clamping structure 700 may include a ratchet retractor thatmay be used to lock the clamping structure 700 in place. The ratchetretractor may have multiple locking positions that allow a variableopening in the surgical location of the patient.

In some embodiments, the retractor may be provided with holes or otherfeatures that allow the placing of pins into the bone 714, therebylocking the surgical guiding tool and retractor into place. In someembodiments, the surgical guiding tool 712 may further include acoupling feature that allows integration of a surgical instrument intothe surgical guiding tool. The coupling feature may have a shape thatmatches the shape of (a part of) the surgical instrument.

FIGS. 8 a and 8 b illustrate an example of a surgical guiding tool 800configured to attach to a spine 810. The surgical guiding tool 800includes a first transverse process clamp 802, a second transverseprocess clamp 804, a spinous process clamp 806, and a guiding element808. The first and second transverse process clamps 802 and 804 includeclamps that are able to provide a secure and stable attachment to thetransverse process portions of the spine 810. The spinous process clamp806 further provides a secure attachment to the spinous process of thespine 810. Any of the clamps described above with respect to FIGS. 2-7may be used for the first and second transverse process clamps 802 and804 and/or the spinous process clamp 806. For example, an overhang ofthe ends (i.e., an undercut portion) of the clamps 802, 804, and/or 806may be created when the surgical guiding tool 800 is placed on the spine810. The undercut portion may form a clamping or snapping mechanism thatencloses the transverse process and creates a stable and secureattachment of the surgical guiding tool 800 to the spine 810. As anotherexample, the clamps 802, 804, and 806 may include a snap-fit portionincluding a flexible structure for increasing a clamping force of theclamps 802, 804, and 806 and allowing ease of removal of the surgicalguiding tool 800 from the spine 810. In some embodiments, the flexiblesnap-fit portion including the flexible structure may include materialhaving a thickness that is less than the average thickness of theremainder of the guide 800, as described above. In some embodiments, theflexible snap-fit portion including the flexible structure may includeone or more attachment mechanisms, as described above, that may includea group of bands, chains, or a honeycomb structure that are made from aflexible material. The surgical guiding tool may further include aguiding element 808. The guiding element 808 may include an aperturethrough which a surgical instrument may be placed. The guiding element808 may further include a drill pin, or any other tool used in asurgical procedure relating to the spine. For example, a drill pin maybe used to lock the guide 800 into place on the spine 810. In someembodiments, any number of clamps may be used to attach the surgicalguiding tool 800 to the spine 810. For example, a clamp may further beused to attach the surgical guiding tool 800 to the lamina, the superiorprocess articular, the pedicle, etc.

In some embodiments, the surgical guiding tools 200, 300, 400, 716,and/or 800 illustrated in FIGS. 2-4, 7, and 8 may include one or morehandle structures (not shown) that protrude from the outer surface ofthe surgical guiding tool. The one or more handle structures may be usedto allow easy manipulation of the guiding tools, such as for handlingthe guiding tools. For example, the one or more handles may be used forplacing the guiding tools over the bone or removing them from the bone.In some embodiments, the handle structures may function to open a clamp,such as clamp 204, 304, 402, 704, 802, 804, and/or 806, of the guidingtool by forcing two or more of the handle structures together. Thus, theone or more handles may allow easier placement or removal of the guidingtool over or from the bone.

FIG. 9 illustrates a method of manufacturing a surgical guiding tool. Atblock 902, the method includes designing the surgical guiding tool tocreate a surgical tool design, wherein the surgical guiding tool designincludes: a body including one or more clamps configured to attach thesurgical guiding tool to one or more portions of a bone, wherein a firstclamp of the one or more clamps includes a snap-fit portion including aflexible structure for increasing a clamping force of the first clampand allowing ease of removal of the surgical guiding tool from the bone,and at least one aperture for guiding a surgical instrument. At block904, the method includes manufacturing the surgical guiding tool basedon the surgical guiding tool design. The surgical guiding tool may bedesigned and/or manufactured according to the pre-operative planningprocedures using patient-specific features of a patient's bone discussedabove. In some embodiments, the snap-fit portion is manufactured toprovide a level of force specified in the design.

In some embodiments, the surgical guiding tools described above arepartially or completely made by additive manufacturing, which allows theintegration of patient-specific components (e.g., the body, the one ormore clamps, the apertures, etc.) that further increases the accuracy ofthe guiding tools. The patient-specific components of the surgicalguiding tools may be designed based on patient-specific parts of aparticular bone of a patient. The patient specific components of thesurgical guiding tools may be made by generating portions that arecomplementary to the patient-specific parts of the bone. For convertingdigital image information of the bone into a basic model, template, ormold that at least in part shows the positive or negative form of atleast a portion of the bone, any suitable technique known in the art maybe used, such as for example a rapid prototyping technique.

Rapid Prototyping and Manufacturing (RP&M) may be defined as a group oftechniques used to quickly fabricate a scale model of an objecttypically using three-dimensional (3-D) computer aided design (CAD) dataof the object. Currently, a multitude of Rapid Prototyping techniquesare available, including stereo lithography (SLA), Selective LaserSintering (SLS), Fused Deposition Modeling (FDM), foil-based techniques,etc.

A common feature of these techniques is that objects are typically builtlayer by layer. Stereo lithography, presently the most common RP&Mtechnique, utilizes a vat of liquid photopolymer “resin” to build anobject a layer at a time. On each layer, an electromagnetic ray, e.g.one or several laser beams which are computer-controlled, traces aspecific pattern on the surface of the liquid resin that is defined bythe two-dimensional cross sections of the object to be formed. Exposureto the electromagnetic ray cures, or, solidifies the pattern traced onthe resin and adheres it to the layer below. After a coat had beenpolymerized, the platform descends by a single layer thickness and asubsequent layer pattern is traced, adhering to the previous layer. Acomplete 3-D object is formed by this process.

Selective laser sintering (SLS) uses a high power laser or anotherfocused heat source to sinter or weld small particles of plastic, metal,or ceramic powders into a mass representing the 3-dimensional object tobe formed.

Fused deposition modeling (FDM) and related techniques make use of atemporary transition from a solid material to a liquid state, usuallydue to heating. The material is driven through an extrusion nozzle in acontrolled way and deposited in the required place as described, forexample, in U.S. Pat. No. 5,141,680, the entire disclosure of which ishereby incorporated by reference.

Foil-based techniques fix coats to one another by means of gluing orphoto polymerization or other techniques and cut the object from thesecoats or polymerize the object.

Typically RP&M techniques start from a digital representation of the 3-Dobject to be formed. Generally, the digital is sliced into a series ofcross-sectional layers which can be overlaid to form the object as awhole. The RP&M apparatus uses this data for building the object on alayer-by-layer basic. The cross-sectional data representing the layerdata of the 3-D object may be generated using a computer system andcomputer aided design and manufacturing (CAD/CAM) software.

A selective laser sintering (SLS) apparatus may be used for themanufacture of a surgical guiding tool template instead of a computermodel. It should be understood however, that various types of rapidmanufacturing and tooling may be used for accurately fabricating thesesurgical templates including, but not limited to, stereolithography(SLA), Fused Deposition Modeling (FDM) or milling.

The surgical guiding tools described above (or parts thereof) may bemanufactured using different materials. In some embodiments, onlymaterials that are biocompatible (e.g. USP class VI compatible) with thehuman body are used. In some embodiments, a surgical guiding tooltemplate may be formed from a heat-tolerable material allowing it totolerate high-temperature sterilization. In some embodiments, if SLS isused as a RP&M technique, the surgical guiding tool template may befabricated from a polyamide such as PA 2200 as supplied by EOS, Munich,Germany or any other material known by those skilled in the art may alsobe used.

The invention disclosed herein may be implemented as a method,apparatus, or article of manufacture using standard programming orengineering techniques to produce software, firmware, hardware, or anycombination thereof. The term “article of manufacture” as used hereinrefers to code or logic implemented in hardware or nontransitorycomputer readable media such as optical storage devices, and volatile ornonvolatile memory devices or transitory computer readable media such assignals, carrier waves, etc. Such hardware may include, but is notlimited to, field programmable gate arrays (FPGAs), application-specificintegrated circuits (ASICs), complex programmable logic devices (CPLDs),programmable logic arrays (PLAs), microprocessors, or other similarprocessing devices.

It will be appreciated by persons skilled in the art that numerousvariations and/or modifications may be made to the invention withoutdeparting from the spirit or the scope of the invention as broadlydescribed. The above described embodiments are, therefore, to beconsidered in all respects as illustrative and not restrictive.

1. A surgical guiding tool for a bone comprising: a body including: oneor more clamps configured to attach the surgical guiding tool to one ormore portions of the bone, wherein a first clamp of the one or moreclamps includes a snap-fit portion including a flexible structure forincreasing a clamping force of the first clamp and allowing ease ofremoval of the surgical guiding tool from the bone, wherein the flexiblestructure of the snap-fit portion includes material having a thicknessthat is between ½ and ⅕ of the average thickness of the remainder of thebody; and at least one aperture for guiding a surgical instrument. 2.(canceled)
 3. The surgical guiding tool of claim 1, wherein the flexiblestructure of the snap-fit portion includes at least one chain connectedbetween a first portion of the first clamp and a second portion of thefirst clamp.
 4. The surgical guiding tool of claim 3, wherein the atleast one chain includes at least one cylinder adding rigidity to the atleast one chain.
 5. The surgical guiding tool of claim 1, wherein theflexible structure of the snap-fit portion includes a honeycombstructure including a plurality of holes that add flexibility andrigidity to the flexible structure.
 6. The surgical guiding tool ofclaim 1, wherein the body further includes a first portion configured toattach the surgical guiding tool to one or more osteophytes on the bone.7. The surgical guiding tool of claim 6, wherein the bone is one of ashoulder or a femur.
 8. The surgical guiding tool of claim 6, whereinthe first portion includes a flexible snap-fit portion for increasing aclamping force of the first portion to the bone and allowing ease ofremoval of the surgical guiding tool from the bone.
 9. The surgicalguiding tool of claim 1, wherein the bone is one of a shoulder or afemur.
 10. The surgical guiding tool of claim 9, wherein the bone is afemur and the one or more portions of the bone that the one or moreclamps are configured to attach the surgical guiding tool to include atleast one condyle of the distal end of the femur.
 11. The surgicalguiding tool of claim 1, wherein the flexible structure includes aflexible material.
 12. A method of manufacturing a surgical guidingtool, the method comprising: designing the surgical guiding tool tocreate a surgical guiding tool design, wherein the surgical tool designincludes body including: one or more clamps configured to attach thesurgical guiding tool to one or more portions of a bone, wherein a firstclamp of the one or more clamps includes a snap-fit portion including aflexible structure for increasing a clamping force of the first clampand allowing ease of removal of the surgical guiding tool from the bone;and at least one aperture for guiding a surgical instrument; andmanufacturing the surgical guiding tool based on the surgical guidingtool design.
 13. The surgical guiding tool of claim 12, furthercomprising identifying the one or more portions of the bone as regionsthat the surgical guiding tool may attach to in order to limitrotational and translational movement of the surgical guiding tool. 14.The surgical guiding tool of claim 13, wherein the bone is one of ashoulder or a femur.
 15. The surgical guiding tool of claim 14, whereinthe bone is a femur and the body further includes a first portionconfigured to attach the surgical guiding tool to one or moreosteophytes on the femur.
 16. The surgical guiding tool of claim 14,wherein the bone is a femur and the one or more portions of the bonethat the one or more clamps are configured to attach the surgicalguiding tool to include one or more condyle of the distal end of thefemur.
 17. A femoral surgical guiding tool for a distal end of a femur,comprising: a body including: an anterior portion configured to attachthe surgical guiding tool to one or more osteophytes on an anteriorregion of the femur; one or more clamps configured to attach thesurgical guiding tool to one or more condyles of the femur; and at leastone aperture for guiding a surgical instrument.
 18. The femoral surgicalguiding tool of claim 17, wherein a first clamp of the one or moreclamps includes an undercut portion that is configured to hook on to afirst condyle of the one or more condyles.
 19. The femoral surgicalguiding tool of claim 17, wherein a first clamp of the one or moreclamps includes a snap-fit portion including a flexible structureconfigured to allow ease of removal of the surgical guiding tool fromthe femur.
 20. The femoral surgical guiding tool of claim 19, whereinthe flexible structure is configured to increase a clamping force of thefirst clamp.